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Background Older adults, who are living in nursing homes that provide a high level of long-term nursing care, are characterized by multimorbidity and a high prevalence of dependency in activities of daily living. Results of recent studies indicate positive effects of structured exercise programs during long-term care for physical functioning, cognition, and psychosocial well-being. However, for frail elderly the evidence remains inconsistent. There are no evidence-based guidelines for exercises for nursing home residents that consider their individual deficits and capacities. Therefore, high-quality studies are required to examine the efficacy of exercise interventions for this multimorbid target group. The purpose of this study is to determine the feasibility and efficacy of a multicomponent exercise intervention for nursing home residents that aims to improve physical and cognitive functioning as well as quality of life. Methods A two-arm single-blinded multicenter randomized controlled trial will be conducted, including 48 nursing homes in eight regions of Germany with an estimated sample size of 1120 individuals. Participants will be randomly assigned to either a training or a waiting time control group. For a period of 16 weeks the training group will meet twice a week for group-based sessions (45–60 min each), which will contain exercises to improve physical functioning (strength, endurance, balance, flexibility) and cognitive-motor skills (dual-task). The intervention is organized as a progressive challenge which is successively adapted to the residents’ capacities. Physical functioning, cognitive performance, and quality of life will be assessed in both study groups at baseline (pre-test), after 16-weeks (post-treatment), and after 32-weeks (retention test, intervention group only). Discussion This study will provide information about the efficacy of a multicomponent exercise program in nursing homes (performance, recruitment). Results from this trial will contribute to the evidence of multicomponent exercises, which specifically focus on cognitive-motor approaches in the maintenance of mental and physical functioning. In addition, it will help to encourage older adults to actively engage in social life. Furthermore, the findings will lead to recommendations for health promotion interventions for frail nursing home residents. Trial registration The trial was prospectively registered at DRKS.de with the registration number DRKS00014957 on October 9, 2018.

In patients with hypertension and pre‐frailty or frailty, the influence of systolic (SBP) and diastolic blood pressure (DBP) time in target range (TTR) on clinical outcomes is unclear. Thus, we conducted a post hoc analysis of the Systolic Blood Pressure Intervention Trial (SPRINT). Classifying 4208 participants into frail and non‐frail groups using a frailty index, the study calculated blood pressure time in target range (BP‐TTR) for the first three months using the Rosendaal method. The primary endpoint included a composite of nonfatal myocardial infarction (MI), acute coronary syndromes, stroke, acute decompensated heart failure (ADHF), and cardiovascular death. Relationships between BP‐TTR and outcomes were analyzed using Kaplan‐Meier curves, Cox models, and restricted cubic spline curves, with subgroup analysis for further insights. In a median follow‐up of 3.17 years, primary outcomes occurred in 6.7% of participants. Kaplan‐Meier analysis showed that a lower systolic blood pressure time in target range (SBP‐TTR) (0%–25%) correlated with an increased cumulative incidence of the primary outcome (p < .001), nonfatal MI (P = .021), stroke (P = .004), and cardiovascular death (P = .002). A higher SBP‐TTR (75%–<100%) was linked to a reduced risk of these outcomes. The restricted cubic spline (RCS) curve revealed a linear association between SBP‐TTR and the primary outcome (non‐linear P = .704). Similar patterns were observed for diastolic blood pressure time in target range (DBP‐TTR). Subgroup analysis showed that the protective effect of higher SBP‐TTR was less pronounced at low DBP‐TTR levels (P for interaction = .023). In conclusion, this study highlights the importance of maintaining BP within the target range to mitigate cardiovascular risks in this population.

Diverse strategies are needed to reduce frailty. This study evaluated the effects of two behavioural interventions targeting outdoor walking on reducing the level of frailty among community-dwelling older adults with mobility limitations. Data from two participant cohorts of the Getting Older Adults Outdoors (GO-OUT) study were analyzed. After baseline evaluations, 190 participants were invited to a one-day educational workshop and were then randomized to either a 10-week supervised outdoor walk group (n = 98) or a 10-week telephone weekly reminders group (n = 92). Frailty was assessed using Fried's frailty index at 0, 3, and 5.5 months. Mixed-effects linear and ordinal regression models were used to evaluate change in frailty score and phenotype over time after accounting for age, sex, study site, participation on own or with a partner, and cohort. At baseline, participant mean age was 74.5 ± 7.1 years; 73% were female, 7% were frail, and 59% were pre-frail. Total frailty scores decreased, on average, by 0.13 points (b = -0.13, 95% CI: -0.26 to -0.01; p = .036) across all participants from 0 to 3 months (immediately post-intervention). Participants were 55% less likely to progress to more severe frailty phenotypes at 3 months compared to baseline (OR=0.45; 95% CI: 0.25 to 0.81; p = .008). No significant between-group differences or long-term effects were observed. A short-term reduction in frailty was observed in older adults with mobility limitations following participation in behavioural interventions aimed at improving outdoor walking; neither intervention was superior. Supervised outdoor walk group and telephone weekly reminder interventions to increase outdoor walking may have the potential to mitigate frailty in older adults with mobility limitations.

Although integrated home internet of things (IoT) services can be beneficial, especially for vulnerable older adults, the hurdle of usability hinders implementation of the technology. This study aimed to evaluate the practical usability of home IoT services in older adults, by frailty status, and to determine the potential obstacles. From August 2019 to July 2020, we randomly selected 20 vulnerable older adults (prefrailty group [ n  = 11], and frailty group [ n  = 9]) who had already been identified as needing home IoT services in a community-based prospective cohort study, the Aging Study of the Pyeongchang Rural Area. Integrated home IoT services were provided for 1 year, and a face-to-face survey evaluating usability and satisfaction of each service was conducted. The usability of the integrated home IoT services declined gradually throughout the study. However, prefrail participants showed higher usability than frail older adults (difference-in-difference = − 19.431, p  = 0.012). According to the frailty status, the change in usability for each service type also showed a different pattern. During the 12-month study period, the service with the highest satisfaction converged from various service needs to light control by remote control (77.8%) in the prefrailty group and automatic gas circuit breaker (72.7%) in the frailty group. For wider implementation of home IoT services, organizing services expected to have high usability and satisfaction based on user’s frailty status is crucial. Also, providing education before service implementation might help older adults coping with digital literacy.

To present the preliminarily findings regarding the effects of a herbal medicine, Ninjin'yoeito, on comorbid frailty and sarcopenia in patients with chronic obstructive pulmonary disease (COPD). Patients with COPD (GOLD II or higher) and fatigue were randomly assigned to Group A (n = 28; no medication for 12 weeks, followed by 12-week administration) or B (n= 25; 24-week continuous administration). Visual analog scale (VAS) symptoms of fatigue, the COPD assessment test (CAT), and the modified Medical Research Council (mMRC) Dyspnea Scale were examined. Physical indices such asknee extension leg strength and walking speed, skeletal muscle mass index (SMI), and respiratory function test were also measured. VAS fatigue scales in Group B significantly improved after 4, 8, and 12 weeks compared to those in Group A (each p<0.001, respectively). Right and left knee extension leg strength in Group B significantly improved after 12 weeks compared to that in Group A (p=0.042 and p=0.037, respectively). The 1-s walking speed for continued to increase significantly over 24 weeks in Group B (p=0.016, p<0.001, p<0.001, p=0.004, p<0.001, and p<0.001 after 4, 8, 12, 16, 20, and 24 weeks, respectively); it also significantly increased after the administration of Ninjin'yoeito in Group A. In Group B, the SMI significantly increased at 12 weeks in patients with sarcopenia (p=0.025). The CAT scores in Group B significantly improved after 12 weeks compared to those in Group A (p=0.006). The mMRC scores in Group B also significantly improved after 8 and 12 weeks compared to those in Group A (p= 0.045 and p <0.001, respectively). The changes in %FEV1.0 in Group B were significantly improved at 12 and 24 weeks (p=0.039 and p=0.036, respectively). Overall, Ninjin'yoeito significantly improved patients' quality of life, physical activity, muscle mass, and possibly lung function, suggesting that Ninjin'yoeito may improve frailty and sarcopenia in patients with COPD.

Background Centenarians comprise an age group characterized by exceptional longevity and low age‐associated pathologies. However, they still experience physiological decline, and different studies have linked frailty to this population. Exercise interventions reverse frailty and improve functional capacity, but no studies have addressed the effect of an intervention in centenarians. In this study, we assessed the impact of a 12‐week resistance exercise intervention in a group of centenarians and characterized their functional capacity as well as the expression of several molecular biomarkers associated with frailty. Methods A total of 19 centenarians were enrolled, but 7 of them did not complete the study. The remaining 12 centenarians were randomly assigned to the control or intervention group, which was a 12‐week resistance exercise intervention. Molecular biomarkers were measured by qRT‐PCR and ELISA. Results The intervention group improved their functional capacity measured by Short Physical Performance Battery (SPPB) (post 5.0 vs 2.3 in pre) and Physical Performance and Mobility Examination (PPME) (6.5 vs 3.8), as well as in frailty status studied by Fried Frailty Phenotype (3.0 vs 3.8) and Frailty Trait Scale 5 (FTS5) (post 30.7 vs 34.0 in pre) scales. ANCOVA revealed that the resistance training led to significant improvements in functional capacity scales SPPB (p = 0.01) and PPME (p < 0.001), as well as Fried Frailty Phenotype (p = 0.001) and FTS5 (p = 0.05). Biomarkers related to frailty (EGR1, miR194‐5p, miR125b‐5p and miR454‐3p) and inflammation (IL‐6 and IL‐1β) showed different expression patterns in centenarians (n = 19) compared to both old (n = 44, average of 79 years old) and young adults (n = 34, average of 29 years old) groups. Notably, the intervention was associated with improvements in frailty and inflammation biomarkers expression. Finally, correlation analyses showed significant associations between all functional and frailty variables, with SPPB correlating with miR454‐3p (ρ = 0.73) and FTS5 correlating with miR454‐3p (ρ = −0.83), IL‐6 (ρ = 0.60) and miR125b‐5p (ρ = −0.55). Conclusions Our results revealed that resistance exercise intervention enhances functional status and reduces frailty in centenarians, and this is associated with improvements in frailty and inflammation biomarkers.

BackgroundThe minimally important difference (MID) for frailty variation associated with adverse outcomes remains unknown in patients with heart failure and preserved ejection fraction (HFpEF), and whether spironolactone can ameliorate frailty progression in this population remains unclear.MethodsWe analysed data from 1767 participants in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. The MID for frailty was calculated using an anchor-based approach, with the EuroQol-Visual Analogue Scale (EQ-VAS) as the anchor. Frailty index (FI), defined as a 35-item cumulative deficit score, and EQ-VAS were assessed at baseline and 1-year follow-up. The primary composite outcome (cardiovascular death, aborted cardiac arrest or heart failure hospitalisation) was assessed from the 1-year follow-up visit. Adjusted Cox proportional hazards models evaluated the link between FI changes (ΔFI≥MID) and the primary outcome. Longitudinal FI changes were analysed using linear mixed-effects models to evaluate spironolactone’s effect.ResultsThe MID for the FI was 0.03 points. An FI reduction ≥MID was associated with a lower risk of the primary composite outcome (aHR, 0.63; 95% CI 0.48 to 0.82), all-cause mortality (aHR, 0.57; 95% CI 0.42 to 0.76) and heart failure hospitalisation (aHR, 0.55; 95% CI 0.40 to 0.75) after adjusting for baseline FI, age, sex, New York Heart Association class, smoking status and treatment assignment. No between-group difference in FI change was observed with spironolactone versus placebo (aOR, 0.85; 95% CI 0.67 to 1.09).ConclusionsFrailty improvement exceeding the 0.03 FI threshold predicts better prognosis in HFpEF, underscoring the value of routine assessment. Spironolactone use was associated with neutral effects on frailty progression in our analysis, suggesting potential safety in this vulnerable population.Trial registration numberNCT00094302.

Background To investigate whether continuous intervention using soymilk containing high soy protein improves physical frailty, a randomized controlled trial was conducted among the Japanese pre-frail and frail elderly. Methods Japanese pre-frail and frail elderly participants ( n  = 73) were randomly assigned to the high-soy protein and control groups, who then ingested soymilk containing 14.5 g/200 ml and 3.2 g/200 ml of soy protein, respectively. Before and after the 12-week intervention, walking speed, skeletal muscle mass, grip strength, and the revised Japanese CHS questionnaire regarding fatigue and physical activity were examined to evaluate the impact of each soymilk on physical frailty and compare the variation between the two groups. Physical activity (monitored using a pedometer), dietary intake (determined by questionnaire), and estimated protein intake (determined by casual urine testing) were also recorded before and after the intervention. Results For the final analysis of the entire cohort ( n  = 70), there were no significant differences in the endpoints between the two groups. In the subgroup analysis, among participants with a walking speed of at least 1 m/s ( n  = 35, P  = 0.012) and at least 5,000 steps/day before intervention ( n  = 27, P  = 0.0083), the variation in walking speed after the 12-week intervention was significantly higher in the high-soy protein group than in the control group. Estimated protein intake was also significantly higher in the high-soy protein group than in the control group after the intervention. Regarding physical activity and dietary intake, no significant differences were observed between the groups before or after the intervention. Conclusion The continuous 12-week intervention of high soy protein increased the walking speed among the Japanese pre-frail and frail elderly participants who had an ordinarily high walking speed and high step counts. Trial registration UMIN Clinical Trials Registry, UMIN000044999. Registered July 29, 2021; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051409 .

AbstractFor clinical studies of sarcopenia and frailty, clinically meaningful outcome measures are needed to monitor disease progression, evaluate efficacy of interventions, and plan clinical trials. Physical performance measures including measures of gait speed and other aspects of mobility and strength have been used in many studies, although a definition of clinically meaningful change in performance has remained unclear. The International Conference on Frailty and Sarcopenia Research Task Force (ICFSR-TF), a group of academic and industry scientists investigating frailty and sarcopenia, met in Miami Beach, Florida, USA in February 2019 to explore approaches for establishing clinical meaningfulness in a manner aligned with regulatory authorities. They concluded that clinical meaningful change is contextually dependent, and that both anchor- based and distribution-based methods of quantifying physical function are informative and should be evaluated relative to patient-reported outcomes. In addition, they identified additional research needed to enable setting criteria for clinical meaningful change in trials.

Background Frailty is a state of low physiological reserve and multi-systemic dysregulation that leads to susceptibility to external stressors; it is associated with adverse outcomes. North American data suggest that haemodialysis recipients are more likely to be frail than the general population, although data on UK cohorts are lacking. Furthermore, with a multitude of assessment tools, it is difficult for the clinician to ascertain which is most suitable for this population. The FITNESS Study aims to measure the prevalence and outcomes associated with frailty in a large UK haemodialysis cohort to determine the optimum frailty tool as defined by predictive value for mortality/hospitalisation and to conduct a feasibility study exploring a multi-disciplinary clinical intervention to improve frailty among haemodialysis recipients. Methods/design The study will follow a cohort multiple randomised controlled trial design; the initial cohort study will identify participants to be invited into a subsequent open-label randomised controlled trial. Eligible patients will be identified and recruited from their usual haemodialysis session. They will be invited to complete tasks and questionnaires collecting data on sarcopenia, immunosenescence, mood, cognition, disability, and comorbidity. Fifty pre-frail participants with suitable English proficiency will be randomly selected from this cohort to participate in the randomised controlled trial phase of the study. Further stratified randomisation will occur to assign these 50 participants to active or passive groups. The active group will receive a psychologically supported, patient-centred, multi-disciplinary intervention into frailty, in what we believe to be a first within this patient group. The control group will receive usual haemodialysis standard of care. All participants will be followed up using electronic patient records for outcomes to include hospitalisation and mortality. Primary outcomes for this phase of the study will be feasibility and tolerability of the clinical intervention study. Discussion The study will collect data on multiple aspects of frailty allowing for a rich dataset for detailed analysis. We believe this will be the first study to explore a psychologically supported, patient-centred intervention in this patient group. Trial registration Clinicaltrials.gov, NCT03071107 . Registered on 6 March 2017.